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Research Associate, Clinical III

The Senior CRA is a critical role at BioMarin, holding key responsibilities for the execution of the clinical trial and driving day-to-day activities to help the clinical operations team support study milestones.

 

Inspection Readiness. 

  • Follow ICH guidelines on essential document collection needed for clinical trial conduct. 
  • Work with site coordinators, CRO monitors, and cross-functional colleagues to gather and organize documents from clinical team, sites, and vendors in trial master file. 
  • Assist with site file inventorying and QC to ensure study record is complete.

Data Integrity

  • Perform data review of study subjects to ensure data accuracy, completeness, and compliance with clinical protocol. 
  • Apply keen attention to detail to verify data quality, and issue queries and protocol deviations as warranted. 
  • Perform reconciliation of lab samples, ptotocol deviations, and other study data. 
  • Work with cross-functional team to resolve issues.

 

Motivation and Organization.

  • Be driven to meet commitments and deliver high quality work on time.       
  • Perform assigned tasks independently, prioritize tasks with help from manager and study leads, and escalate issues as necessary. 
  • Demonstrate initiative in all aspects.  

Team Work and Communication

  • Work closely with other members of the clinical operations team and proactively offer support wherever needed. 
  • Collaborate with cross-functional teams, adapt to changing timelines with composure, and exhibit enthusiasm to supply on-time deliverables.

Bachelor's degree.

 

At least 2 years of experience working as a CRA or equivalent preferred. 

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